Bharat Biotech | Covaxin | Ocugen Bharat Biotech to conduct clinical trials for Covaxin in US, Canada
Hyderabad/IBNS: Bharat Biotech will conduct clinical trials for Covaxin in United States and Canada as its US partner Ocugen has said that it will apply for a full licence in the United States for the India-made vaccine.
Clinical trials will have to be conducted to fulfill the requirements of biologics licence application.
Therefore, the vaccine will now be tested on US participants but it is not known whether it will be a large scale study or a small trial.
The company will not apply for emergency use authorisation again after being denied by the Food and Drug Administration (FDA).
Bharat Biotech has been criticized for delaying in publishing its Phase 3 clinical trial data.
The Hyderabad-based company had said that it would publish the Phase 3 clinical trial data in June.
After FDA's denial in granting approval to the Indian vaccine for emergency use in the United States, Bharat Biotech has said that it is not a setback and it is fully committed to maintaining transparency.
In its defence, Bharat Biotech has said there is sufficient data to prove the efficacy of its vaccine.
Nine research studies to prove the safety and efficacy of a vaccine have been published in five globally reputed peer reviewed journals, Bharat Biotech has said.
It also said that Covaxin is the only product that has any data on emerging variants and the studies are the first to publish any data from human clinical trials in India.
The company is now going to pursue full licensing which no vaccine produced in India has received so far in the US.
Bharat Biotech's US partner Ocugen has said that it will also pursue an emergency use approval application in Canada for Covaxin.
It has managed to secure Covaxin's commercialization rights in Canada.
Currently, Covaxin is being administered in six countries while it has secured emergency use authorisation has been obtained in 13 countries
If Covaxin gets full licence in the United States, it will be a huge development as no vaccine manufactured or developed in India has ever received emergency use authorisation or full licence from US FDA.
Currently, Bharat Biotech is conducting clinical trials on children between the age of 12 to 18 years.
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